Hikma Pharmaceuticals USA INC: Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Ber
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Hikma Pharmaceuticals USA INC
- Product
- Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59.
- Reason / hazard
- This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide.
- Recall initiated
- 2026-04-07
- Code info
- Lot # AC2040A, Exp Date: 04/2026
- Product quantity
- 4 single dose 75 ml bottles
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Columbus
- State
- OH
- Country
- United States
- Event id
- 98744
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